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International generic name (More at www.nivalin.com)
Galantamine
Drug form and composition
Solution for injection. One ampoule of 1 ml contains 1 mg (0.1%); 2.5 mg (0.25%);
5 mg (0.5%) or 10 mg (1%) Galantamine hydrobromide. Tablets. One tablet contains
5 mg or 10 mg Galantamine hydrobromide.
Indications
Nivalin is indicated during the convalescence and residual phase of poliomyelitis;
neuritis; radiculitis; polineuritis; spastic paresis and paralysis; myopathia; myasthenia
gravis; progressive muscular dystrophy; cerebral paralysis in children; birth paralysis;
nycturia; residual paresis following a brain hemorrhage and some forms of impotence;
mild and moderate Alzheimer’s disease; in order to suppress the effect of the nondepolarizing
neuro-muscular blockers. As an antidote in morphine intoxication.
Dosage and administration
The solution for injection is applied subcutaneous, intramuscularly or intravenously.
The treatment is started with the lowest effective dose, which is gradually increased.
Maximal single dose in adults is 10 mg, the maximal dose is 20 mg /24 hours. In
children is used subcutaneous in following daily doses: 1-2 years - 0.25 - 1 mg;
3-5 years - 0.5-5 mg; 6-8 years - 0.75-7.5 mg; 9-11 years - 1-10 mg; 12-15 years
- 1.25-12.5 mg; over 15 years - 12.5-15 mg. As a curare antidote Nivalin is used
intravenously in following doses: In children 1-2 years - 1-2 mg; 3-5 years - 1.5-3
mg; 6-8 years - 2-5 mg; 9-11 years - 3-8 mg; 12-15 years - 5-10 mg; In adults -
10-20 mg. Nivalin solution for injection could be applied by electrophoresis in
dose 1-2 ml, 0.25% solution. Tablets are used orally, 1 hour after nutrition in
following doses: children 6-8 years - 5-10 mg daily; 9-11 years - 5-15 mg daily;
12-15 years - 5-25 mg; in adults 10-40 mg daily, divided in 2-3 takes. The treatment
should continue 1-2 months; in degenerative diseases of CNS the treatment may continue
up to 1 year.
Contraindications
Nivalin is contraindicated in hypersensitivity to galantamine; bronchial asthma;
bradycardia; atrioventricular block; angina pectoris; heart failure; epilepsy; hyperkinesis;
gastrointestinal tract or urinary tract obstruction.
Special warnings and precautions
In patients with renal failure Nivalin should be used with care and in lower
doses, depending on the creatine clearence. In pregnant and nursing women the treatment
with Nivalin is not advisable.
Drug interactions
Nivalin reduces the action of the M-choline receptor blocking agents, ganglion-blocking
agents, nondepolarizing myorelaxants; chinine and novocain-amide. Amynoglycoside
antibiotics may reduce the therapeutic effect of Nivalin in miasthenia gravis. The
action-time of the neuromuscular blocking agents may be protracted in concomitant
administration of Nivalin.
Adverse reactions
Adverse reactions are result of the parasympathetic action of Nivalin and include
hypersalivation; sweating; vomiting; dizziness, rarely bradycardia. In such cases
the dose should be reduced or the treatment should be discontinued within 2-3 days.
Pharmacological mechanisms
The active agent of Nivalin is the alkaloid galantamine, isolated by an original
technology from the flower Leukojum aestivum. It possesses a powerful reversible
inhibiting effect on the enzyme acetylcholine esrterase, predominantly in the CNS
and less significant in the peripheral nervous system. It passes easy the hematoencephal
barrier, which makes the preparation equally effective both in oral and parenteral
administration. Nivalin facilitates impulse conduction in the CNS and VNS, as well
as in neuromuscular synapse with resultant restoration of the neuromuscular conduction,
enhancement of the smooth muscle tone, gastrointestinal and sweat gland secretion
increase, and excitation of the respiratory center by reflector and central mechanisms.
Nivalin improves memory function in patients with cognitive deficiency, due to different
types dementia.
Supplied
10 or 100 ampoules of 1 ml (0.1%; 0.25%; 0.5% or 1%). 60 tablets of 5 mg. 20
tablets of 10 mg.
Expiry
Solution for injection and tablets- 5 years.
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